U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Probe, radiofrequency lesion - Product Code GXI
Causa
Straight needle labeled as a curved needle.
Acción
NeuroTherm notified consignees by telephone between February 2- March 15, 2013 about the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The incorrect dfu was packaged with two lots of gdc 360 degree detachable coils.
Acción
The firm, Stryker Neurovascular, sent an "URGENT: Field Safety Notification" dated 3/21/2016 via courier to its consignees/customers. The notification describes the product, problem and actions to be taken. The customers were instructed to immediately check your inventory; follow the instructions listed in the Directions For Use (DFU); circulate and maintain the notice internally to all interested/affected parties; inform Stryker if any of the subject devices have been distributed; complete and return the FIELD SAFETY CORRECTIVE ACTION AKNOWLEDGMENT FORM to Stryker via fax at 1 (866) 876-4355 within 7 calendar days, as well as notify any other organizations that the device may have been distributed to.
Should you have any queries concerning this matter contact Quality Manager at 510-413-2593 or email: Geraldine.ahern@stryker.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The incorrect dfu was packaged with two lots of gdc 360 degree detachable coils.
Acción
The firm, Stryker Neurovascular, sent an "URGENT: Field Safety Notification" dated 3/21/2016 via courier to its consignees/customers. The notification describes the product, problem and actions to be taken. The customers were instructed to immediately check your inventory; follow the instructions listed in the Directions For Use (DFU); circulate and maintain the notice internally to all interested/affected parties; inform Stryker if any of the subject devices have been distributed; complete and return the FIELD SAFETY CORRECTIVE ACTION AKNOWLEDGMENT FORM to Stryker via fax at 1 (866) 876-4355 within 7 calendar days, as well as notify any other organizations that the device may have been distributed to.
Should you have any queries concerning this matter contact Quality Manager at 510-413-2593 or email: Geraldine.ahern@stryker.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com